Approval Probability
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MET233 · 2 trials · 2 indications
For Part A, B, C, D, E and G
| Arm | Type | Description |
|---|---|---|
| Part A Cohort | EXPERIMENTAL | Cohort participants will receive single co-administered ascending dose (SAD) of subcutaneous (SC) MET233 and SC MET097 or matched SC placebo. |
| Part B Cohort | EXPERIMENTAL | Cohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo. |
| Part C Cohort | EXPERIMENTAL | Cohort Participants will receive multiple doses of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with T2DM. |
| Part D Cohort | EXPERIMENTAL | Cohort Participants will receive multiple doses of weekly and monthly (ie, every 4 weeks \[QM\]) co-administered SC MET233 with SC MET097, or matched SC placebo in participants with obesity. |
| Part E Cohort | EXPERIMENTAL | Cohort Participants will receive multiple dose QW-to-QM of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with obesity. |
| Part G Cohort | EXPERIMENTAL | Cohort Participants will receive multiple dose cohort of QW and QM SC MET097 monotherapy or matched SC placebo in participants with obesity or overweight. |
| (Part A) MET233 | EXPERIMENTAL | Participants will receive a single dose of MET233 at up to 5 dose levels |
| (Part A) Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| (Part B) MET233 | EXPERIMENTAL | Participants will receive five weekly doses of MET233 at up to 4 dose levels |
| (Part B) Placebo | PLACEBO_COMPARATOR | Participants will receive five weekly doses of placebo |
| (Part C) MET233 | EXPERIMENTAL | Participants will receive twelve weekly doses of MET233 at up to 4 dose levels, followed by a 13th potential monthly dose |
| (Part C) Placebo | PLACEBO_COMPARATOR | Participants will receive twelve weekly doses of placebo, followed by a 13th potential monthly dose |
| (Part D) MET233 | EXPERIMENTAL | Participants will receive twelve weekly doses of MET233, followed by three monthly doses. |
| (Part D) Placebo | PLACEBO_COMPARATOR | Participants will receive twelve weekly doses of placebo, followed by three monthly doses. |
| Name | Type | Description |
|---|---|---|
| MET233 and MET097 | DRUG | For subcutaneous administration |
| Placebo | OTHER | Sterile 0.9% (w/v) saline for subcutaneous administration. |
| MET097 | DRUG | For subcutaneous administration |
| MET233 | BIOLOGICAL | For subcutaneous administration |
Inclusion Criteria: * Adult males or females aged 18 to 75 years (inclusive) at the time of screening. * BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2...
MET233 is being developed for the treatment of obesity and overweight, as well as obesity-related medical conditions. It is an investigational small molecule that is not yet approved for any indication. Metsera, Inc. is studying it both as a single agent and in combination with MET097 in adults with obesity or overweight.
MET233 is being developed by Metsera, Inc., which trades under the ticker MTSR. The company is advancing the program in early clinical development for obesity and overweight, including a combination study with MET097.
MET233 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency. The program includes a completed Phase 1 study and an ongoing Phase 1 combination study in adults with obesity or overweight.
MET233 has been studied in two Phase 1 trials. NCT07022977 evaluated MET233 alone in individuals with obesity or overweight and is completed. NCT06924320 is evaluating MET233 in combination with MET097 in individuals with obesity or overweight with or without diabetes and is currently recruiting.
No. MET233 and MET097 are distinct drug candidates. MET233 is being studied both as a monotherapy and in combination with MET097 in a Phase 1 trial for obesity and overweight. The two are separate investigational agents rather than alternative names for the same molecule.